Metal-on-Metal Hip Implants: Report a Problem

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.Reports to the FDA about adverse events related to metal-on-metal hip systems include, but are not limited to: pain, malposition, adverse local tissue reaction, metallosis, hypersensitivity (allergy), loosening, and dislocation.

Manufacturers

When possible, please report all information obtained from retrieval analyses. This may include, but not limited to: histology of the surrounding tissue, adverse wear patterns and the range of wear particle diameter size, length and aspect ratio.

Physicians

If a physician suspects an adverse event with a metal-on-metal device, FDA encourages you to file a voluntary report through our MedWatch, the FDA Safety Information and Adverse Event Reporting program. To help us learn as much as possible about the adverse events associated with metal-on-metal hip implants, please include the following information in your reports, if available:

Contact Information:

If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) via e-mail at dice@fda.hhs.gov or by phone: 800-638-2041 (toll-free) or 301-796-7100.